REXLON, REXSIL

Suture, Nonabsorbable, Synthetic, Polyamide

SM ENG CO., LTD

The following data is part of a premarket notification filed by Sm Eng Co., Ltd with the FDA for Rexlon, Rexsil.

Pre-market Notification Details

Device IDK161633
510k NumberK161633
Device Name:REXLON, REXSIL
ClassificationSuture, Nonabsorbable, Synthetic, Polyamide
Applicant SM ENG CO., LTD 46, NAKDONG-DAERO 1302BEON-GIL Sasang-gu,  KR
ContactSoon-gu Lee
CorrespondentSanglok Lee
WISE COMPANY INC. #306, 3 DAERIM-RO 27GA-GIL Yeongdeungpo-gu,  KR 07413
Product CodeGAR  
CFR Regulation Number878.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-13
Decision Date2017-03-02
Summary:summary

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